Skip to main content
High RiskFDA
Medline Industries Inc
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube...
Drugs·994,756 affected·Sep 17, 2018
High RiskFDA
Sterilmed, Inc.
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (1...
Cardiac Devices·218 affected·Sep 17, 2018
High RiskFDA
Beckman Coulter Inc.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpe...
Medical Devices·41 affected·Sep 17, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI700020...
Medical Devices·641 affected·Sep 17, 2018
High RiskFDA
Biomerieux Sa
NucliSENS¿ Magnetic Extraction Reagents
Diagnostic Devices·42 affected·Sep 17, 2018
High RiskFDA
Livanova Usa Inc.
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-...
Cardiac Devices·6 affected·Sep 14, 2018
High RiskFDA
Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for...
Diagnostic Devices·12,700 affected·Sep 14, 2018
High RiskFDA
Ecolab Inc
Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical D...
Surgical Devices·344 affected·Sep 14, 2018
High RiskFDA
Ecolab Inc
Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vi...
Surgical Devices·88 affected·Sep 14, 2018
High RiskFDA
Brett Anthony Foods
Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups per case. Refrigerated. UPC 85392700334
Food·88 affected·Sep 13, 2018
High RiskFDA
Swanson Health Products, Inc
Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson ...
Food·953 affected·Sep 13, 2018
High RiskFDA
Ardent Mills, Llc
Safeguard Soft Flr (GIV) packaged in 50 lb bags
Food·7,500 affected·Sep 13, 2018
High RiskFDA
Lidl Us Trading
Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor, 5.3 oz. (150g) package contai...
Dairy·52,000 affected·Sep 13, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Medical Devices·152 affected·Sep 13, 2018
High RiskFDA
Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains...
Medical Implants·832 affected·Sep 13, 2018
High RiskFDA
Coca Cola Bottling Compan
Sprite 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 49...
Food·309 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product; NET WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder,...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Black Sesame White Chocolate (cookies); A Sarap Asian Fusion Product; Net WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Bakin...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Coca Cola Bottling Compan
NO SUGAR NO CALORIES Diet Coke 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL...
Food·794 affected·Sep 12, 2018
High RiskFDA
Sarap Asian Fusion
Matcha Chocolate (cookies); A Sarap Asian Fusion Product; NET WT. 70 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Mi...
Dairy·0 affected·Sep 12, 2018
High RiskFDA
Coca Cola Bottling Compan
CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-...
Food·24 affected·Sep 12, 2018
High RiskFDA
Synthes (usa) Products Llc
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intend...
Medical Devices·20 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Li...
Medical Devices·400 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a ...
Medical Devices·158,163 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·281,350 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·136,800 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·456,071 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin...
Medical Devices·40 affected·Sep 12, 2018
High RiskFDA
Howmedica Osteonics Corp.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrume...
Medical Devices·58 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to ...
Medical Devices·110,134 affected·Sep 12, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Sabor Brasil Queijo Minas Frescal Cheese Net Wt. 17.6 oz (498g) UPC 19753-00049 Keep Refrigerated.
Dairy·40 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Lupita Panela Fresca, Mexican Style Farmer's Cheese. Net Wt. 17.6 oz (498g) UPC 19753-00608 Keep Refrigerated.
Dairy·25 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Mimoso Queijo Minas Fresco Farmer's Cheese. Net Wt. 12 oz (340g) UPC 19753-00052 Keep Refrigerated.
Dairy·320 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Mimoso Queijo Minas Frescal. Net Wt. 28 oz (793g) UPC 19753-0050 Keep Refrigerated.
Food·160 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Campesino Colomblano Style Farmers Cheese. Net Wt. 17.6 oz (498g) UPC 19753-00090 Keep Refrigerated.
Dairy·50 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
La Campina Queso De Freir Fresh Frying Cheese. Net Wt. 10 oz (283g) UPC 19753-00073 Keep Refrigerated.
Dairy·50 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Taino Queso de Hoja, Puerto Rico Style Cheese. Net Wt. 17.6 oz (498g) UPC 19753-0094 Keep Refrigerated.
Dairy·25 affected·Sep 11, 2018
High RiskFDA
Love Corn Usa
Love Corn, Sea Salt , Net WT. 1.6 Oz. Bags of 10 per cases
Food·1,404 affected·Sep 11, 2018
High RiskFDA
Wisconsin Cheese Group, Llc
Sabor Brasil Queijo Minas / Minas Farmer's Cheese. Net Wt. 3 lbs / 1.36kg UPC 19753-00075 Keep Refrigerated.
Dairy·50 affected·Sep 11, 2018
High RiskFDA
Torrent Pharma Inc.
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 A...
Oral Drugs·15,384 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for...
Medical Devices·28,004 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording...
Medical Devices·6,458 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording ...
Medical Devices·6,864 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit ...
Medical Devices·33,065 affected·Sep 11, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1...
Injectable Drugs·9 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
Injectable Drugs·881 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
Drugs·815 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D...
Injectable Drugs·609 affected·Sep 10, 2018